Principles and Practices of Returning Individual Research Results to Participants in Large Studies of Pregnancy and Childhood.

Investigators conducting human subject research have typically conveyed only clinically actionable results back to individual participants. Shifting scientific culture around viewing participants as partners in research, however, is prompting investigators to consider returning as much data or results as the participant would like, even if they are not clearly actionable. Expanding return of individual results may add value for individual participants and their communities, refine future research questions and methods, build trust, and enhance retention of participants. Yet, gaps remain in understanding the implications of these changes for groups of 'vulnerable' participants, including pregnant and pediatric participants. We present the findings of a National Institutes of Health workshop on returning individual research results, particularly as applicable to pregnant and pediatric participants. Research participants who were panelists at the workshop agreed that they desire to receive their results. Workshop findings and current literature indicate that participants have differing preferences for what results they receive. One way to address the limits of current practice is to develop flexible digital platforms that convey individual results along with researchers' availability to answer questions, and to provide as much information as possible about actionable steps to control environmental exposures associated with disease risk.

ReCAP: Impact of Multidisciplinary Care on Processes of Cancer Care: A Multi-Institutional Study.

PURPOSE: The role of multidisciplinary care (MDC) on cancer care processes is not fully understood. We investigated the impact of MDC on the processes of care at cancer centers within the National Cancer Institute Community Cancer Centers Program (NCCCP). METHODS: The study used data from patients diagnosed with stage IIB to III rectal cancer, stage III colon cancer, and stage III non­small-cell lung cancer at 14 NCCCP cancer centers from 2007 to 2012. We used an MDC development assessment tool­with levels ranging from evolving MDC (low) to achieving excellence (high)­to measure the level of MDC implementation in seven MDC areas, such as case planning and physician engagement. Descriptive statistics and cluster-adjusted regression models quantified the association between MDC implementation and processes of care, including time from diagnosis to treatment receipt. RESULTS: A total of 1,079 patients were examined. Compared with patients with colon cancer treated at cancer centers reporting low MDC scores, time to treatment receipt was shorter for patients with colon cancer treated at cancer centers reporting high or moderate MDC scores for physician engagement (hazard ratio [HR] for high physician engagement, 2.66; 95% CI, 1.70 to 4.17; HR for moderate physician engagement, 1.50; 95% CI, 1.19 to 1.89) and longer for patients with colon cancer treated at cancer centers reporting high 2MDC scores for case planning (HR, 0.65; 95% CI, 0.49 to 0.85). Results for patients with rectal cancer were qualitatively similar, and there was no statistically significant difference among patients with lung cancer. CONCLUSION: MDC implementation level was associated with processes of care, and direction of association varied across MDC assessment areas.

Assessing the Development of Multidisciplinary Care: Experience of the National Cancer Institute Community Cancer Centers Program.

PURPOSE: The National Cancer Institute Community Cancer Centers Program (NCCCP) began in 2007 with a goal of expanding cancer research and delivering quality care in communities. The NCCCP Quality of Care (QoC) Subcommittee was charged with developing and improving the quality of multidisciplinary care. An assessment tool with nine key elements relevant to MDC structure and operations was developed. METHODS: Fourteen NCCCP sites reported multidisciplinary care assessments for lung, breast, and colorectal cancer in June 2010, June 2011, and June 2012 using an online reporting tool. Each site evaluated their level of maturity (level 1 = no multidisciplinary care, level 5 = highly integrated multidisciplinary care) in nine elements integral to multidisciplinary care. Thematic analysis of open-ended qualitative responses was also conducted. RESULTS: The proportion of sites that reported level 3 or greater on the assessment tool was tabulated at each time point. For all tumor types, sites that reached this level increased in six elements: case planning, clinical trials, integration of care coordination, physician engagement, quality improvement, and treatment team integration. Factors that enabled improvement included increasing organizational support, ensuring appropriate physician participation, increasing patient navigation, increasing participation in national quality initiatives, targeting genetics referrals, engaging primary care providers, and integrating clinical trial staff. CONCLUSIONS: Maturation of multidisciplinary care reflected focused work of the NCCCP QoC Subcommittee. Working group efforts in patient navigation, genetics, and physician conditions of participation were evident in improved multidisciplinary care performance for three common malignancies. This work provides a blueprint for health systems that wish to incorporate prospective multidisciplinary care into their cancer programs.

Improving quality of cancer care at community hospitals: impact of the National Cancer Institute Community Cancer Centers Program pilot.

PURPOSE: Patients with cancer treated at community hospitals may experience decreased quality of care compared with patients treated at higher-volume cancer hospitals. The National Cancer Institute Community Cancer Centers Program (NCCCP) pilot is designed to enhance research and improve cancer care at community hospitals. We assessed changes in quality of care among the 16 initial NCCCP sites versus 25 similar hospitals that did not participate in the NCCCP. METHODS: We compared changes in concordance with five National Quality Forum-approved quality of care measures (three for breast cancer, two for colon cancer) for patients diagnosed from 2006 to 2007 (pre-NCCCP initiation) versus 2008 to 2010 (post-NCCCP initiation) at NCCCP and comparison-group hospitals. Data were collected using the Commission on Cancer Rapid Quality Reporting System. Analyses were performed using multivariate logistic regression. RESULTS: Analyses included 18,608 patients with breast cancer and 7,031 patients with colon cancer. After NCCCP initiation, patient-level concordance rates for all five quality-of-care measures increased significantly among NCCCP and comparison-group hospitals. Increased quality of care among NCCCP sites was significantly greater than that among comparison-group hospitals for radiation therapy after breast-conserving surgery and hormonal therapy for women with hormone receptor-positive breast cancer. In multivariate regressions, increases in hormonal therapy among NCCCP-site patients were significantly greater than those among comparison-group hospitals. CONCLUSION: Both NCCCP and comparison-group hospitals showed improved quality of care; however, NCCCP sites had significantly greater improvements for a subset of measures. This greater increase may reflect the multidisciplinary focus of the NCCCP. Because many individuals receive cancer treatment at community hospitals, facilitating high-quality care in these environments must be a priority.

The organization of multidisciplinary care teams: modeling internal and external influences on cancer care quality.

Quality cancer treatment depends upon careful coordination between multiple treatments and treatment providers, the exchange of technical information, and regular communication between all providers and physician disciplines involved in treatment. This article will examine a particular type of organizational structure purported to regularize and streamline the communication between multiple specialists and support services involved in cancer treatment: the multidisciplinary treatment care (MDC) team. We present a targeted review of what is known about various types of MDC team structures and their impact on the quality of treatment care, and we outline a conceptual model of the connections between team context, structure, process, and performance and their subsequent effects on cancer treatment care processes and patient outcomes. Finally, we will discuss future research directions to understand how MDC teams improve patient outcomes and how characteristics of team structure, culture, leadership, and context (organizational setting and local environment) contribute to optimal multidisciplinary cancer care.

Breast cancer survival among economically disadvantaged women: the influences of delayed diagnosis and treatment on mortality.

Breast cancer affects thousands each year in the United States, and disproportionately affects certain subgroups. For example, the incidence of breast cancer in South Carolina is lower in African American compared with European American women by approximately 12% to 15%, but their mortality rate is twice as high as in European American women. The purpose of the study was to assess factors associated with breast cancer mortality between African American and European American women. Participants (n=314) in South Carolina's Breast and Cervical Cancer Early Detection Program (SCBCCEDP), which provides breast cancer screening and treatment services, during the years 1996-2004 were included in the study. Data, including tumor characteristics, delay intervals, and race, were examined using the chi(2) test and the Wilcoxon rank-sum test. Cox regression modeling was used to assess the relationship between delay intervals and other factors. No racial differences were found in age at diagnosis, tumor characteristics, or delay intervals. Time delay intervals did not explain differences and mortality rates by race. Survival, however, was affected by prognostic factors as well as by a significant interaction between hormone-receptor status and race. Despite the excellent record of the SCBCCEDP in screening and diagnostic or treatment referrals, the racial disparities in breast cancer mortality continue to exist in South Carolina. These findings highlight the need for future research into the etiology of racial differences, and their impact on breast cancer survival.

Understanding barriers for adherence to follow-up care for abnormal pap tests.

OBJECTIVE: Approximately 4000 women annually will die from preventable and treatable cervical cancer. Failure to adhere to follow-up recommendations after an abnormal Pap test can lead to development of cervical cancer. This paper summarizes the body of literature on adherence to follow-up after an abnormal Pap test in order to facilitate development of interventions to decrease morbidity and mortality due to cervical cancer. METHODS: We conducted a comprehensive search of published literature addressing risk factors for adherence or interventions to improve adherence following an abnormal Pap test as the outcome. We included peer-reviewed original research conducted in the United States from 1990 to 2005. RESULTS: Fourteen analytical and twelve experimental studies that met our criteria were reviewed. Lesion severity and health beliefs were consistently associated with adherence rates. Communication interventions, including telephone reminders, counseling, and educational sessions, increased follow-up compliance across intervention studies. Inconsistent evidence for associations among race, income, and age were found. CONCLUSIONS: Further research is needed to reinforce current studies addressing health beliefs and social support. Interventions that focus on the interplay among psychological, educational, and communication barriers are necessary. These interventions should be adapted and applied across various racial/ethnic and socioeconomic groups to reach all women with a high-risk profile for invasive cervical cancer.

What predicts adherence to follow-up recommendations for abnormal Pap tests among older women?

OBJECTIVE: To address socio-demographic factors associated with adherence to follow-up recommendations in a high-risk population of women referred for follow-up care after an abnormal Pap test. METHODS: 486 women aged 46-64 served by BCCEDP in two southeastern states between 1999-2002 and referred for follow-up care after an abnormal Pap test were the sampling frame for this cross-sectional study; 204 women completed a phone-based interview in 2004. Cox proportional hazards modeling was used to determine the association of various risk factors with time to adherence. RESULTS: Among those completing the phone interview (interview rate=61.4%) the mean age was 53.3 years, 64.7% were African-American women, 81.9% had low-grade cervical lesions, and all were either uninsured or under insured. Over 95% received follow-up care for an abnormal Pap test within 365 days of referral. When the BCCEDP criteria of follow-up within 60 days were applied, 52.9% were adherent. Rates of self-reported and program documented adherence differed significantly by state. After adjusting for state of residence, women who reported having symptoms of a chronic disease were more likely to be adherent within 365 days (aHR=1.42; 95% CI=1.00, 2.04). Neither age, race, lesion severity, education, number of dependent adults or children, self-perceived physical health, nor smoking status was associated with time to adherence. CONCLUSIONS: Findings suggest that institutional factors may be more important than individual factors in predicting time to adherence for an abnormal Pap test.